SILDENAFIL 25 mg Film-Coated Tablets

Зміст інструкції

1. Sildenafil Accord 25 mg film-coated tablets
   1. What is Sildenafil Accord and what is it used for
   2. What you need to know before taking Sildenafil Accord
   3. How to take Sildenafil Accord
   4. Possible side effects
   5. How to store Sildenafil Accord
   6. Package contents and other information

Sildenafil Accord 25 mg film-coated tablets

Sildenafil Accord 50 mg film-coated tablets
Sildenafil Accord 100 mg film-coated tablets
Generic medicine
Read this leaflet carefully before taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Sildenafil Accord is and what it is used for
• 2. What you need to know before you take Sildenafil Accord
• 3. How to take Sildenafil Accord
• 4. Possible side effects
• 5. How to store Sildenafil Accord
• 6. Contents of the pack and other information

1. What is Sildenafil Accord and what is it used for

Sildenafil Accord contains the active ingredient sildenafil which belongs to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It helps to relax the blood vessels in the penis, allowing
blood flow to the penis when it is sexually excited. Sildenafil Accord will only help you to get an erection
if you are sexually stimulated.
Sildenafil Accord is a treatment for adult men who experience erectile dysfunction, sometimes called
impotence. This condition occurs when a man cannot achieve or maintain an erection
suitable for sexual intercourse.

2. What you need to know before taking Sildenafil Accord

Do not take Sildenafil Accord

• If you are allergic (hypersensitive) to sildenafil or any of the other ingredients of Sildenafil Accord (see section 6).
• If you are taking medicines called nitrates, because this combination can lead to a dangerous drop in blood pressure. Tell your doctor if you are taking any of these medicines which are often used to relieve angina attacks (or “chest pain”). If you are unsure, ask your doctor or pharmacist.
• If you are taking one of the medicines known as nitric oxide donors like amyl nitrite (“poppers”), because this combination can cause a dangerous drop in blood pressure.
• If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). It has been shown

that PDE5 inhibitors, like Sildenafil Accord, increase the hypotensive effect of this medicine. If you are
taking riociguat or if you have any doubts, tell your doctor.

• If you have a serious heart or liver problem.
• If you have recently had a stroke or a heart attack, or if you have low blood pressure.
• If you have a rare hereditary eye disease (such as retinitis pigmentosa).
• If you have previously experienced loss of vision caused by a non-arteritic anterior ischaemic optic neuropathy (NAION).

Warnings and precautions
Tell your doctor, pharmacist or nurse before taking Sildenafil Accord

• If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of the blood cells) or multiple myeloma (cancer of the bone marrow).
• If you have a deformity of the penis or Peyronie’s disease.
• If you have heart problems. Your doctor will need to carefully check that your heart condition allows you to cope with the exertion of sexual activity.
• If you currently have a stomach ulcer, or problems with blood clotting (such as haemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Sildenafil Accord and contact your doctor immediately.
• You must not use Sildenafil Accord together with other oral or local treatments for erectile dysfunction.
• You must not take Sildenafil Accord with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.
• You must not take Sildenafil Accord if you do not have erectile dysfunction.
• You must not take Sildenafil Accord if you are a woman.

Special precautions for patients with kidney or liver problems
Tell your doctor if you have kidney or liver problems. Your doctor may decide to give you a lower dose.

Children and adolescents
Sildenafil Accord must not be given to anyone under the age of 18 years.

Other medicines and Sildenafil Accord:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Sildenafil Accord may interfere with some medicines, particularly those used for the treatment of
chest pain. If a medical emergency should occur, you should inform your doctor, pharmacist or
nurse that you have taken Sildenafil Accord and when you took it. Do not take Sildenafil Accord
with other medicines unless your doctor has authorised it.
You must not take Sildenafil Accord if you are taking medicines called nitrates, because the combination
of these medicines can lead to a dangerous drop in blood pressure. Always tell your doctor,
pharmacist or nurse if you are taking any of these medicines which are often used to relieve
angina attacks (or “chest pain”).
You must not take Sildenafil Accord if you are taking one of the medicines known as nitric oxide
donors, such as amyl nitrite (“poppers”), because this combination can also lead to a dangerous
drop in blood pressure.
Tell your doctor or pharmacist if you are already taking riociguat.
If you are taking medicines called protease inhibitors, for example for the treatment of HIV, your
doctor may initially prescribe Sildenafil Accord at the lowest dose (25 mg).
Some patients taking alpha-blockers for high blood pressure or
enlarged prostate may experience dizziness or lightheadedness which can be caused by low blood pressure when sitting or standing up quickly. Some patients have
reported these symptoms when they have taken Sildenafil Accord together with alpha-blockers. This is more
likely to happen within 4 hours of taking Sildenafil Accord. To reduce the possibility of these
symptoms occurring, you should take a regular daily dose of your alpha-blocker before starting
treatment with Sildenafil Accord. Your doctor may start you on a lower dose of Sildenafil
Accord (25 mg).
Tell your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used for
the treatment of heart failure.

Taking Sildenafil Accord with food and drink and alcohol
Sildenafil Accord can be taken with or without food. However, you may notice that the onset of the effect of
Sildenafil Accord may be slower if you take it after consuming a heavy meal.
Drinking alcohol may temporarily impair your ability to get an erection. To
get the maximum benefit from this medicine, it is advisable to avoid consuming excessive amounts of
alcohol before using Sildenafil Accord.

Pregnancy, breastfeeding and fertility
Sildenafil Accord is not indicated for use in women.

Driving and using machines
Sildenafil Accord can cause dizziness and may alter your vision. Before driving or using machines you must
be aware of how you react to Sildenafil Accord.

Important information about some of the ingredients of Sildenafil Accord
Sildenafil Accordcontains lactose monohydrate. If your doctor has told you that you have an intolerance to some
sugars, contact your doctor before taking Sildenafil Accord.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially ‘sodium-free’.

3. How to take Sildenafil Accord

Always take Sildenafil Accord exactly as your doctor or pharmacist has told you. If you have any doubts
consult your doctor or pharmacist. The recommended initial dose is 50 mg.

You must not take Sildenafil Accord more than once a day.
You should take Sildenafil Accord approximately one hour before the anticipated sexual activity. Swallow the tablet
whole with a glass of water.
If you feel that the effect of Sildenafil Accord is too strong or too weak, consult your doctor or
pharmacist.
Sildenafil Accord will only help you to achieve an erection if you are sexually stimulated. The time it takes
for Sildenafil Accord to take effect varies from person to person, but generally takes from
half an hour to one hour. The effect of Sildenafil Accord may be delayed if you have recently eaten a heavy
meal.
If Sildenafil Accord does not help you to achieve an erection or if the erection does not last long enough
to complete sexual intercourse, inform your doctor.

If you take more Sildenafil Accord than you should
You may notice an increase in the undesirable effects and their severity. Doses greater than 100 mg do not
increase efficacy.
You should not take a number of tablets greater than that which has been told to you by your doctor.
Consult your doctor if you have taken more tablets than you should.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects reported in association with the use of Sildenafil Accord are generally mild to moderate in severity
and of short duration.

If you experience any of the following serious side effects, stop taking Sildenafil Accord and
contact your doctor immediately:

• Allergic reaction - occurs uncommonly(may affect up to 1 in 100 people) Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain - occurs uncommonlyIf it occurs during or after sexual activity
• Sit in a semi-sitting position and try to relax Do not use nitratesfor chest pain

Prolonged and sometimes painful erections – occur rarely(may affect up to 1 in 1,000)
Prolonged and sometimes painful erections have been reported occasionally after taking Sildenafil Accord. If
this type of erection persists uninterrupted for more than 4 hours, contact your doctor immediately.

• Sudden decrease or loss of vision - occurs rarely
• Severe skin reactions - this occurs rarelySymptoms may include severe peeling and swelling of the skin, blisters of the mouth, genitals and around the eyes, fever.
• Convulsions or seizures - occur rarely

Other side effects:
Very common(may affect more than 1 in 10 people)

• headache

Common(may affect up to 1 in 10 people)

• facial flushing
• hot flushes (symptoms include a sudden feeling of heat in the upper body)
• nausea
• indigestion
• visual disturbances (increased intensity of colors, blurred vision)
• nasal congestion
• dizziness

Uncommon(may affect up to 1 in 100 people)

• vomiting
• skin rash
• eye irritation
• bloodshot eyes/red eyes
• eye pain
• seeing flashes of light
• visual brightness
• sensitivity to light
• heartbeat racing
• fast heartbeat
• high blood pressure
• low blood pressure
• muscle pain, drowsiness
• decreased sensitivity to touch
• vertigo
• ringing in the ears
• dry mouth
• nasal congestion or sinusitis
• inflammation of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion)
• upper abdominal pain
• gastro-esophageal reflux disease (symptoms include heartburn)
• feeling tired
• feeling of warmth
• pain in the arms or legs
• nosebleeds
• blood in urine
• tearing

Rare(may affect up to 1 in 1,000):

• heart attack
• irregular heartbeat
• fainting
• stroke
• temporary reduction of blood flow to certain areas of the brain
• feeling of throat tightening
• numbness of the mouth
• bleeding in the back of the eye
• double vision
• reduced visual acuity
• abnormal sensation in the eye
• swelling of the eyes or eyelids
• seeing small particles or spots
• pupil dilation
• discoloration of the white part of the eye
• penile bleeding
• blood in semen
• dry nose
• swelling of the inside of the nose
• feeling irritable
• sudden decrease or loss of hearing

Cases of unstable angina (a heart condition) and sudden death have been reported rarely from post-marketing
experience. It should be noted that most, but not all, men who experienced these side effects had pre-existing
heart problems before taking this medicine. It is not possible to determine whether these events were directly
related to the use of Sildenafil Accord.

Reporting suspected adverse reactions
If you get any side effects, even those not listed in this leaflet, tell your doctor, or pharmacist or nurse.
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sildenafil Accord

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use Sildenafil Accord after the expiry date which is indicated on the carton label and on the aluminium of the
blister after ‘Exp.’. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sildenafil Accord contains
The active ingredient is sildenafil. Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil as
sildenafil citrate.
The other ingredients are:

• Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, hypromellose 5cp (E464), magnesium stearate.
• Film coating: hypromellose 15cp (E464), titanium dioxide (E171), lactose monohydrate, triacetin, aluminium lake containing indigo carmine (E132) ( see section 2: Important information on certain ingredients of Sildenafil Accord)

Description of the appearance of Sildenafil Accord and package contents
Sildenafil Accord 25 mg tablets are film-coated tablets, blue in colour, almond-shaped,
biconvex, with ‘25’ imprinted on one side and smooth on the other.
Sildenafil Accord 50 mg tablets are film-coated tablets, blue in colour, almond-shaped,
biconvex, with ‘50’ imprinted on one side and smooth on the other.
Sildenafil Accord 100 mg tablets are film-coated tablets, blue in colour, almond-shaped,
biconvex, with ‘100’ imprinted on one side and smooth on the other.
Sildenafil Accord is available in blisters in packs of:
25 mg: 2, 4, 8 or 12 tablets.
50 mg: 2, 4, 8, 12 or 24 tablets.
100 mg: 2, 4, 8, 12 or 24 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Member State Medicinal product name
Czech Republic Sildenafil Accord 100mg
Denmark Sildenafil Accord 25mg /50mg/100mg
Estonia Sildenafil Accord 50mg/100mg
Finland Sildenafil Accord 50mg/100mg
France Sildenafil Accord 25mg /50mg/100mg
Ireland Sildenafil Accord 25mg /50mg/100mg
Italy Sildenafil Accord 25mg /50mg/100mg film-coated tablets
Latvia Sildenafil Accord 50mg/100mg
Lithuania Sildenafil Accord 50mg/100mg
Sweden Sildenafil Accord 25mg /50mg/100mg
Netherlands Sildenafil Accord 25mg /50mg/100mg
United Kingdom Sildenafil Accord 25mg /50mg/100mg